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BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

This study has been terminated.
(One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.)
Sponsor:
Collaborator:
Abbott
Information provided by:
Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00414284
First received: December 20, 2006
Last updated: December 6, 2010
Last verified: December 2010

December 20, 2006
December 6, 2010
June 2006
April 2007   (final data collection date for primary outcome measure)
To evaluate the pharmacokinetic parameters of higher doses of LPV/r
Not Provided
Complete list of historical versions of study NCT00414284 on ClinicalTrials.gov Archive Site
  • To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r
  • To evaluate change in CD4 count after increased dose LPV/r
  • To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID
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BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)
Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of Lopinavir/Ritonavir(LPV/r) in Individuals Experiencing Viremia on Standard Dose LPV/r Using LPV/r Tablet Formulation

This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).

There are several reasons for low level viremia in patients on Kaletra (LPV/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. Little is known about the pharmacokinetics (PK), tolerability and safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be a one time, optional, optimization of background regimen of NRTIs two weeks after the first dose escalation.

Major Eligibility Criteria:

  • CD4 count: > 50
  • Viral load: 200-75,000 on two most recent measures
  • Current treatment: > 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other PI or NNRTI allowed
  • Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Increased dose of Kaletra
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CD4 Count >50
  • Viral load 200-75,000 on two most recent measures
  • More than 16 weeks on standard dose Kaletra (LPV/r)
  • May be initial PI regimen or prior PI usage
  • Up to 50-fold resistance to LPV/r

Exclusion Criteria:

  • Age < 18 years old
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00414284
06-124, IND #71128
Not Provided
Not Provided
Community Research Initiative of New England
Abbott
Principal Investigator: Calvin J Cohen, MD, MSc CRI
Community Research Initiative of New England
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP